Employers, government agencies, sports teams and other organizations have become increasingly involved in diagnostic testing to maintain safety in the workplace and to assure compliance with laws, rules and regulations. The presence of a predetermined analyte (e.g. drugs and/or disease) is determined by collecting biological fluids, i.e., urine, blood, sputum, pleural, cavity and peritoneal cavity fluids, for analysis. It is often vital in conducting such tests to maintain the integrity of the collected biological fluid specimens by minimizing or eliminating any potential for specimen contamination and/or by preserving the chain of custody.
There are many and varied known devices for collecting specimens. A particular device consists of a vial fitted with a heavy-duty screw cap attached to the vial with a tether. The integrity of the device depends on a plastic, easily broken, thus tamper evident, tape that is sealed across the cap and vial. When the specimen is collected, the donor can see that the tape is unbroken, which remains unbroken until the screw cap is removed in the donor's presence. The specimen is then placed in the tube, the cap replaced and the capped tube is shipped to a testing lab.
There are a number of deficiencies in such a system, one of which being that once the tape is broken, there is no longer any tamper evident mechanism, and the chain of custody must be maintained by other means, for example by affidavits and/or testimony. Another deficiency is that if care is taken by someone dedicated to the task, such a tape seal can be removed to unscrew the cap, and then the cap and tape can be replaced without the tampering being evident. Particularly for demonstrating integrity and chain of custody in drug testing, there is a need for a reliable mechanism that enables the donor of the specimen to be assured not only that the container for the specimen is uncontaminated, but to also assure that it is sealed against contamination when shipped to a testing laboratory.